Imaging inflammation in neck artery plaques to study future stroke risk
Tests a PET scan tracer for plaque inflammation in people with stroke or TIA.
Plain-language title generated from the registry record
Registry title: [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a recent stroke or high-risk mini-stroke (TIA) linked to a narrowed carotid artery in the neck. Participants have a PET/MRI scan and are followed by phone.
- Age
- Over 18 years.
- Sex
- All sexes can join.
- Disease stage
- A recent ischemic stroke or high-risk TIA (ABCD2 score 4 or more) in the carotid artery area, with carotid artery narrowing of 30% or more. The stroke or TIA happened no more than 21 days before the tracer was given.
- Earlier treatment
- No carotid endarterectomy or carotid artery stenting in the past year. No current treatment with corticosteroids or somatostatin analogues.
- Biomarker or test result
- A CT angiography scan from routine care must be available. Kidney function (eGFR) must be 40 ml/min/1.73m² or higher.
Main reasons for not taking part
- Pregnant or breast-feeding women
- Stroke caused by the heart, by small vessels, or by another defined cause
- Cannot have or tolerate an MR scan
- Kidney function (eGFR) below 40 ml/min/1.73m²
- Unwilling or unable to do all the study procedures
Read by machine on 12 November 2026.
Where in Belgium
- UZ LeuvenLeuven, BelgiumContact: Louise Maes, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Trial code
- NCT07104487
- Record updated
- 11 August 2025
- Original description
This clinical trial aims to evaluate whether [¹⁸F]AlF-OC PET/MRI can characterize and quantify inflammation in carotid atherosclerotic plaques. The study will assess if tracer uptake in culprit and non-culprit carotid arteries, measured by standardized uptake values (SUV), is associated with future cerebrovascular events. Specifically, it will examine whether [¹⁸F]AlF-OC uptake predicts the risk of recurrent ipsilateral TIA, amaurosis fugax, stroke, or other vascular complications.Read full original descriptionShow less
An Exploratory Study of [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
This clinical trial aims to evaluate whether [¹⁸F]AlF-OC PET/MRI can characterize and quantify inflammation in carotid atherosclerotic plaques. The study will assess if tracer uptake in culprit and non-culprit carotid arteries, measured by standardized uptake values (SUV), is associated with future cerebrovascular events. Specifically, it will examine whether [¹⁸F]AlF-OC uptake predicts the risk of recurrent ipsilateral TIA, amaurosis fugax, stroke, or other vascular complications.
Participants will undergo [¹⁸F]AlF-OC PET/MRI and will be followed via telephone interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA.
Inclusion: Participant is aged over 18 years; Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedure; CT angiography imaging at baseline should be available as part of routine care; Participant is diagnosed with a recent ischemic stroke or high-risk TIA (ABCD2 ≥ 4) in the carotid artery territory and ≥ 30% carotid artery stenosis. The stroke/TIA has occurred no more than 21 days prior to tracer administration.
Exclusion: Participant has a previous or ongoing recurrent or chronic disease at high risk to interfere with the performance or evaluation of the trial, according to the judgment of the investigator; Participants treated with carotid endarterectomy or carotid artery stenting within the past year; Concurrent treatment with corticosteroids and/or somatostatin analogues; Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification (23); Subject has an impaired renal function estimated glomerular filtration rate (eGFR) < 40 ml/min/1.73m² (the last known value may not date from more than 3 months prior to the study PET/MR; if not available a blood analysis may be performed as part of the trial); Female who is pregnant or breast-feeding; Subject has a contra-indication for or cannot tolerate MR scanning; Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator.